(74 days)
Not Found
No
The device description details a purely mechanical surgical instrument with no mention of software, data processing, or any AI/ML related terms.
Yes
The device is intended for the destruction of spider veins, which is a medical treatment for a medical condition, regardless of whether it's for cosmetic or health reasons.
No
The device is described as a "manual surgical instrument intended for use in the destruction of spider veins." Its function is to physically disrupt and destroy veins, not to diagnose conditions.
No
The device description clearly details a physical, mechanical surgical instrument with a handle, shaft, tines, and a rack and gear mechanism. It is not software-only.
Based on the provided information, the VENX REVOLUTION™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the destruction of spider veins in the lower extremities of the body. This is a direct surgical intervention on the patient's body.
- Device Description: The device is a manual surgical instrument designed to physically disrupt and destroy veins in vivo (within the living body).
- Lack of In Vitro Activity: IVD devices are used to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The VENX REVOLUTION™ does not perform any such analysis on specimens.
The VENX REVOLUTION™ is clearly a surgical device used for a therapeutic procedure performed directly on the patient.
N/A
Intended Use / Indications for Use
The VENX REVOLUTION™ is a manual surgical instrument intended for use in the destruction of spider veins in the lower extremities of the body.
Product codes (comma separated list FDA assigned to the subject device)
79 GAH
Device Description
The VENX REVOLUTION™ is a sterile, disposable, single patient use surgical instrument for the disruption and destruction of spider veins located in the lower extremities of the body. The device is made available in several sizes to accommodate a range of veins that form in the lower body. The VENX REVOLUTION™ consists of a thermoplastic handle containing a lever actuated rack and gear mechanism for rotating a shaft extending from the handle. At the end of the shaft are stainless steel, needle-like tines sharpened and spaced appropriately to straddle veins located just below the surface of the skin. Once the tines are in place straddling the vein, the levers are actuated causing the shaft to rotate approximately 360° or more. Actuating the levers causes internal springs to compress. Once the levers have rotated the shaft 360° and the tines have disrupted the vein, releasing the levers allows the compressed springs to return the tines to their original position. The device is then withdrawn and re-inserted at another position within the clinician-selected area to repeat the operation on the same vein or on another vein. The procedure is repeated until all veins within the selected area have been treated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower extremities of the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Bench testing has been conducted using simulated actual use conditions comparing the new device and its ability to disrupt and destruct spider veins to that of the predicate device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing has been conducted using simulated actual use conditions comparing the new device and its ability to disrupt and destruct spider veins to that of the predicate device. The results of the testing show the new device to perform as intended and equivalent to the predicate device. Testing included tine deformation, cycle life, and rotating mechanism operation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
K110355
510(k) Summary
VENX LLC 510(k) Notification Submission
APR 2 2 2011
Date: January 31, 2011
Submitted by: VENX LLC 2701 NW 2nd Avenue, Suite 218 Boca Raton, FL 33431
561-237-5008 Phone: 561-237-5040 Fax:
Contact: Navroze Mehta
Manual Surgical Instrument
Common Name: Manual Surgical Instrument
Trade Name: VENX REVOLUTION™
Classification Name:
Classification: Class I per 21 CFR 878.4800
Predicate Device: Advanced Medical Products, Arachnophlebectomy Needle (K000932)
Description:
The VENX REVOLUTION™ is a sterile, disposable, single patient use surgical instrument for the disruption and destruction of spider veins located in the lower extremities of the body. The device is made available in several sizes to accommodate a range of veins that form in the lower body. The VENX REVOLUTION™ consists of a thermoplastic handle containing a lever actuated rack and gear mechanism for rotating a shaft extending from the handle. At the end of the shaft are stainless steel, needle-like tines sharpened and spaced appropriately to straddle veins located just below the surface of the skin. Once the tines are in place straddling the vein, the levers are actuated causing the shaft to rotate approximately 360° or more. Actuating the levers causes internal springs to compress. Once the levers have rotated the shaft 360° and the tines have disrupted the vein, releasing the levers allows the compressed springs to return the tines to their original position. The device is then withdrawn and re-inserted at another position within the clinician-selected area to repeat the operation on the same vein or on another vein. The procedure is repeated until all veins within the selected area have been treated.
Intended Use:
The VENX REVOLUTION™ is a manual surgical instrument intended for use in the destruction of spider veins in the lower extremities of the body.
Comparison to Predicate Devices:
The VENX REVOLUTION™ differs from the predicate device only in the mechanism for rotating the device tines. The predicate device relied on the clinician to manually rotate the pen-like device within the fingers to disrupt the vein. The VENX REVOLUTION™™
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110355
Page 2 of 2
VENX LLC
510(k) Notification Submission
incorporates a lever-actuated mechanism to rotate the tines a minimum 360° by actuating levers with the fingers. The basic construction, and available sizes of the tines remain unchanged.
Testing:
Bench testing has been conducted using simulated actual use conditions comparing the new device and its ability to disrupt and destruct spider veins to that of the predicate device. The results of the testing show the new device to perform as intended and equivalent to the predicate device. Testing included tine deformation, cycle life, and rotating mechanism operation.
Conclusion:
In accordance with the Food, Drug, and Cosmetic Act and 21 CFR 807, and based on the information provided in the premarket notification, VENX LLC concludes that the VENX REVOLUTION™ is safe, effective and substantially equivalent to the predicate device discussed herein.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Venx. ILC % MRI Medical Mr. Ira Duesler 4700 S. Overland Drive Tucson, Arizona 85714
APR 2 2 2011
Re: K110355 Trade Name: Venx Revolution™ Classification Regulation Name and Number: Manual Surgical Instrument for General Use,
21 CFR 878.4800
Regulatory Class: Class I Exempt Product Code: 79 GAH (Stylet, Surgical, General & Plastic Surgery) Dated: January 31, 2011 Received: February 7, 2011
Dear: Mr. Duesler
We have reviewed your premarket notification submission and have found this device to be exempt from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (Act). Therefore, you may immediately begin marketing this device as described in your premarket notification.
The final classification regulation for your device appears in Title 21 of the Code of Federal Regulations (CFR) 878.4800. We suggest that you review this regulation since it may grant other exemptions from certain general controls of the Act. Your device classification regulation name, regulatory class, and product code are shown above. When listing your device with the Food and Drug Administration, please use this product code.
In the future, new but substantially equivalent devices which fall within the above classification regulation name and meet the classification criteria may be marketed without sending a premarket notification submission to the Food and Drug Administration. We suggest, however, that you review 21 CFR Section 878.9 to determine whether or not your new device meets the limitations of exemption from Section 510(k) of the Act.
If you have any questions regarding this letter, please contact George J.Mattamal, Ph.D at (301) 796-6396 or the Division of Small Manufacturers, International and Consumer Assistance at its
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Page 2 - Mr. Ira Duesler
toll free number (800) 638-2041 or (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh/dsmamain.html.
Sincerely yours,
A.J. B. n h
fer
Mark N. Melkerson Director Division of Surgical, Orthopedic and Reconstructive Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications For Use
510(k) Number (if known): K110355
Device Name: VENX REVOLUTION™
Indications For Use:
The VENX REVOLUTION™ is a manual surgical instrument intended for use in the destruction of spider veins in the lower extremities of the body.
Prescription Device × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nel R.P. Ayde firmen
(Division Sign Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110355
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